Assessing heart disease and diabetes risk in women during and after pregnancy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study focuses on women who experience placental complications during pregnancy, such as pre-eclampsia and gestational hypertension, to evaluate their risk factors for developing heart disease and diabetes. The study will recruit women actively trying to conceive and follow them through their pregnancy and up to 12 months postpartum. Additionally, a control group of women not planning pregnancy will be included to compare outcomes. The goal is to understand how placental syndromes impact long-term cardiovascular health and to identify potential preventive measures.

Why it matters

Who can join: the full rules

Pregnancy Arm Inclusion Criteria:

To be included in the trial the participant must:

* Nulliparous (no previous pregnancy beyond 20 weeks' gestation)
* Actively considering pregnancy within approximately 12 months
* Aged between 18 and 45 years
* Ability to consent and willing to participate

Pregnancy Arm Exclusion Criteria:

The presence of any of the following will preclude participant inclusion:

* Currently pregnant
* Established infertility
* Planning or actively using fertility treatments (e.g. IVF, ICSI, FET, IUI)
* Assigned male sex at birth
* Autoimmune disease (e.g. rheumatoid arthritis, lupus)
* Thrombophilia
* Type 1 diabetes
* Known advanced chronic kidney disease (stages 4-5)
* Malignant hypertension
* Clinically manifest CVD (e.g. previous myocardial infarction, stroke)
* Active cancer/being treated for cancer currently (other than skin cancer)
* Any other condition preventing full participation in the study

Non-Pregnancy Arm Inclusion criteria

To be included in the trial the participant must:

* Nulliparous (no previous pregnancy beyond 20 weeks' gestation)
* Not planning to conceive during next 18 months
* Aged between 18 and 45 years
* Ability to consent and willing to participate

Non-Pregnancy Exclusion Criteria

The presence of any of the following will preclude participant inclusion:

* Currently pregnant
* Planning or actively using fertility treatments (e.g. IVF, ICSI, FET, IUI)
* Assigned male sex at birth
* Autoimmune disease (e.g. rheumatoid arthritis, lupus)
* Thrombophilia
* Type 1 diabetes
* Known advanced chronic kidney disease (stages 4-5)
* Malignant hypertension
* Clinically manifest CVD (e.g. previous myocardial infarction, stroke)
* Active cancer/being treated for cancer currently (other than skin cancer)
* Any other condition preventing full participation in the study

Where it's running

• Cambridge University Hospitals NHS Foundation Trust
  Cambridge, United Kingdom Recruiting
• NHS Greater Glasgow and Clyde
  Glasgow, United Kingdom Recruiting
• Imperial College Healthcare NHS Trust
  London, United Kingdom Recruiting
• University College London Hospitals NHS Foundation Trust
  London, United Kingdom Not yet recruiting
• King's College Hospital NHS Foundation Trust
  London, United Kingdom Not yet recruiting
• St George's University Hospitals NHS Foundation Trust
  London, United Kingdom Not yet recruiting

Study contacts

• Principal investigator: Ian Wilkinson, MD — Cambridge University Hospitals NHS Foundation Trust
• Study coordinator: Heike Templin
• Email: cuh.poppycctu@nhs.net
• Phone: 0044 1223 250874

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.